Parexel Blog

As a former regulator, Jorge shares his perspectives for the need of more faster endpoints to measure how targeted cancer drugs can benefit patients. He believes it can be created by combining two...

When developing cell and gene therapies (CGTs), drug companies face significant hurdles. One of which is getting insurance companies to pay for these treatments that can potentially cure patients...

Biotech companies are the driving force behind the industry’s R&D pipeline as they develop and launch increasingly complex treatments. With more than 80% of the assets in development managed by...

Once the full fury of the pandemic was understood, the Food and Drug Administration turned to a number of tools that already existed to help fill the gap for information that was normally...

Now that the presidential election in the United States has come and gone and there will be an expected change in administrations in January, 2021 one of the questions that has been raised is...

Pediatric participation in clinical trials is essential to understanding how drugs perform in children, whose side effects and responses to medications are often very different from adults. Yet...

In the Federal Register notice, FDA reiterated that drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients.

The extraordinary challenges of 2020—the global pandemic and the renewed campaign against racial injustice—have simultaneously presented opportunities for significant growth and change across the...

When we discuss innovation in clinical trials, it’s easy to think first of technologies involving digital health or evolving tools such as augmented intelligence. And these are certainly...

In the latest turn of the long and winding road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM).

This blog focuses on unpacking the important points made in the companion Guidance for Industry – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and...

Despite the best efforts of the pandemic, the FDLI delayed but did not cancel its annual meeting for 2020 and hosted the event through a virtual platform. In this blog, I’ll walk through the...

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For any company on the receiving end of an FDA 483 or warning letter, standard operating procedures (SOPs) represent an opportunity to simultaneously achieve compliance and improve operational...

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FDA has previously made several public statements about its ability to conduct inspections and FDA personnel have also made policy comments in various public forums. Now that this guidance has...

The EO creates several new requirements aimed at building reliable, long-term domestic production of essential drugs and devices, including their components and input materials. These include...

There are a plethora of different devices available, ranging from commercially available actigraphy to specialized and medically approved devices. This article is designed to help sponsors...

Our regulatory affairs experts outline the new EAEU guidelines, and an effort to create global standards across the board. Read more...